Infusion pump assembly and method

ABSTRACT

Some embodiments of an infusion pump assembly may be equipped with one or more components to facilitate wireless operation of an infusion pump via a user-operated mobile device. In some embodiments, the mobile device and/or the infusion pump may prompt the user to confirm acceptance of a wirelessly communicated command to prevent an operation by the infusion pump (e.g., a dispensation of medicine) that is not desired by the user.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of and claims priority toU.S. application Ser. No. 14/453,596, filed on Aug. 6, 2014. Thedisclosure of the prior application is considered part of the disclosureof this application, and is incorporated in its entirety into thisapplication.

TECHNICAL FIELD

This document relates to an infusion pump assembly, such as a portableinfusion pump assembly for dispensing a medicine.

BACKGROUND

Pump systems are commonly used to deliver one or more fluids to atargeted individual. For example, a medical infusion pump system may beused to deliver a medicine to a patient as part of a medical treatment.The medicine that is delivered by the infusion pump system can depend onthe condition of the patient and the desired treatment plan. Forexample, infusion pump systems have been used to deliver insulin to thevasculature of diabetes patients so as to regulate blood-glucose levels.

Users of infusion pump devices often need to communicate with theinfusion pump via a user interface to control the operations of theinfusion pump in a safe and effective manner. For example, a user maypress a series of buttons on the user interface to enter food intakedata into the infusion pump, such as a number of grams of carbohydratesthat is indicative of a recently or soon-to-be consumed meal. The foodintake data can be combined by the infusion pump assembly with otherparameters to calculate a suggested dosage of insulin based on the gramsof carbohydrates entered by the user. In another example, a user mayenter information into the infusion pump assembly via a user interfacethat indicates that the user is going to perform a level of physicalexercise. In some circumstances, the infusion pump system may reduce theamount of a planned dispensation of insulin in response to the exerciseinformation entered by the user.

In some systems, a wireless remote controller is provided to facilitatewireless and operation of an infusion pump assembly. Wireless remotecontrol of the pump assembly, however, introduces two primary concernsregarding patient safety: 1) A concern that a third-party could controlthe pump assembly by hijacking the wireless connection between the pumpassembly and the remote controller; and 2) A concern that a virus,programming error, or a third-party application interfering with theremote controller could adversely affect operation of the pump assembly.

SUMMARY

Some embodiments of an infusion pump system may be equipped with one ormore components to facilitate wireless communication between a mobilecommunication device and an infusion pump assembly. In some embodiments,the mobile device (e.g., a smartphone) can wirelessly transfer data tothe infusion pump assembly that may cause the pump assembly to execute aparticular sequence of operations (e.g., operations to provide acontrolled dispensation of medicine). In particular, the mobile devicemay communicate one or more user input commands to the infusion pumpassembly (e.g., user input commands that might otherwise be input via aseries of menu selections and data entry steps on the user interface ofthe infusion pump assembly) to initiate a suggested bolus dosage ofinsulin (or another medication). In some embodiments, the smartphonedevice is operable to execute a dosage calculator application thatdetermines the suggested bolus dosage based on information indicative ofthe user's blood glucose level. In some embodiments, the smartphonedevice and/or the infusion pump assembly may prompt the user to confirmacceptance of the suggested bolus dosage to prevent a dispensation ofmedicine that is not desired by the user.

Particular embodiments described herein provide a medical infusion pumpsystem including a portable pump housing configured to receive insulinfor dispensation to a user, a controller communicatively coupled withthe pump drive system, and a wireless communication device configured toreceive a suggested dosage amount from a mobile device. The pump housingmay at least partially contain a pump drive system to dispense theinsulin through a flow path to the user, and the controller can beoperable to cause controlled dispensation of the insulin from theportable pump housing by the pump drive system. In some embodiments, thecontroller may, in response to receiving the suggested dosage amountfrom the mobile device, prompt the user for confirmation of acceptanceof the suggested dosage.

In some optional aspects, the system may further include the mobiledevice, and the mobile device may include a memory device that stores amobile application configured to receive blood glucose information ofthe user and food consumption information of the user. The mobile devicemay be a smartphone device. The controller may be configured to promptthe user for confirmation of acceptance of the suggested bolus dosage bytransmitting a confirmation signal to the mobile device indicatingreceipt of the suggested dosage amount to cause the mobile device toprompt the user to provide at least one of a security code and abiometric validation to confirm acceptance of the suggested bolusdosage. The system may further include a glucose monitoring deviceconfigured to be worn by the user and configured to wirelesslycommunicate blood glucose information of the user. The system mayfurther include a blood strip reader device configured to determine ablood glucose level of the user. The blood strip reader device may beconfigured to wirelessly communicate blood glucose information of theuser.

Other embodiments described herein provide a method that includesreceiving input via wireless communication from a mobile device, such assmartphone device, that is indicative of a task to be performed by aportable infusion pump system. The may also include prompting a user toconfirm, via interaction with the portable infusion pump system, achange in operation of the portable infusion pump system according tothe input received from the smartphone device.

In some optional aspects, the method may further include activating thechange in operation of the portable infusion pump system in response tothe user's confirmation via interaction with the portable infusion pumpsystem. The user's confirmation via interaction with the portableinfusion pump system may include bumping the smartphone device inproximity to the portable infusion pump system such that both thesmartphone device and the portable infusion pump system detect a bumpmotion. The user's confirmation via interaction with the portableinfusion pump system may include input via a touchscreen or button ofthe portable infusion pump system. The method may also optionallyinclude rejecting the change in operation of the portable infusion pumpsystem after lapse of a predetermined period of time in which no useconfirmation is received. The method may further include rejecting thechange in operation of the portable infusion pump system after receivinginput from the user, via interaction with the portable infusion pumpsystem, indicative of a rejection of the change in operation. The inputreceived from the smartphone device may include information indicativeof a calculated bolus dosage. The input received from the smartphonedevice may include information indicative of a temporary basal rate. Thesmartphone device may execute a mobile application configured to outputa suggested change in operation of the portable infusion pump.

In some embodiments described herein, a system may include a smartphonedevice including a memory device (e.g., a RAM memory module, anothercomputer-readable memory device, or the like) storing computer-readableinstructions that cause the smartphone to access a dosage calculatorapplication, and a wireless communication device of the smartphonedevice configured to wirelessly communicate with a portable infusionpump system. Optionally, the dosage calculator application is configuredto calculate a suggested bolus dosage that is wirelessly communicated tothe portable infusion pump system, and the smartphone device wirelesslyreceives information indicative of a user's confirmation of thesuggested bolus dosage.

In some optional aspects, the system may further include the portableinfusion pump system, and the portable infusion pump system may beconfigured to prompt the user for confirmation of acceptance of thesuggested bolus dosage. The system may also optionally include a glucosemonitoring device configured to be worn by the user and configured towirelessly communicate blood glucose information of the user to thesmartphone device. The system may optionally include a blood stripreader device configured to determine a blood glucose level of the userand configured to wirelessly communicate blood glucose information ofthe user to the smartphone device.

In some embodiments described herein, a medical infusion pump system mayinclude a portable pump housing configured to receive insulin fordispensation to a user. The system may also include a controllercommunicatively coupled with the pump drive system. Also, the system mayinclude a mobile device communicatively coupled with the controller toprovide a trigger signal via a wireless connection to initiatedispensation of the insulin according to a bolus dosage. The pumphousing at least partially contains a pump drive system to dispense theinsulin through a flow path to the user, and the controller is operableto cause controlled dispensation of the insulin from the portable pumphousing by the pump drive system. In some circumstances, in response toreceiving the trigger signal, the controller prompts the user forconfirmation of acceptance of the bolus dosage.

In some embodiments described herein, a method may include receivinginput from a mobile device that is indicative of a task to be performedby a portable infusion pump system. The method may further includereceiving, via near field communication (NFC) from a NFC device (e.g.,an NFC tag or an NFC circuit) incorporated in the mobile device, asignal indicative of a user's confirmation of acceptance of a change inoperation of the portable infusion pump system according to the inputreceived from the mobile device. The method may also include, inresponse to receiving the signal, controlling the portable infusion pumpsystem according to the user-confirmed change in operation.

In other embodiments described herein, a method may include transmittinginput via wireless communication from a smartphone device that isindicative of a task to be performed by a portable infusion pump system.The method may also include prompting a user to confirm, via interactionwith the smartphone device, a change in operation of the portableinfusion pump system according to the input transmitted from thesmartphone device.

Some or all of the embodiments described herein may provide one or moreof the following advantages. First, some embodiments of the infusionpump system may be configured to send and receive data communicationswirelessly using NFC and/or short-range wireless communicationtechnology implemented on a mobile device and an infusion pump assembly,thereby providing convenient wireless communications while also reducingthe likelihood of long-range hijacking of the wireless communications tothe infusion pump assembly. Second, some embodiments of an infusion pumpsystem may provide safe and reliable wireless control of an infusionpump assembly by a mobile device. Third, some embodiments of theinfusion pump system may facilitate user confirmation of a pump-assemblyoperation initiated wirelessly via the mobile device to prevent suchoperations that are unintended by the user. Fourth, some embodiments ofan infusion pump system may facilitate convenient user input ofinformation to the infusion pump assembly via a smartphone operated bythe user. Fifth, some embodiments of an infusion pump system equippedwith wireless communication capabilities may be configured to beportable, wearable, and (in some circumstances) concealable. Forexample, a user can conveniently wear one or more components of theinfusion pump system on the user's skin under clothing or can carry suchcomponents in the user's pocket (or other portable location) whilereceiving medicine dispensed from an infusion pump device. Sixth, insome embodiments of an infusion pump system, the user can wirelesslyoperate an infusion pump assembly without removing the pump assemblyfrom a portable and concealed location. Seventh, in some embodiments ofan infusion pump system, a mobile device configured to wirelesslyoperate the infusion pump assembly can include a dosage calculatorsoftware application that accurately calculates a suggested bolus dosagebased on data indicative the user's blood glucose level. Eight, in someembodiments of the infusion pump system, the software application mayutilize the bolus calculation feature in combination with a glucosemonitoring device and/or a blood glucose test strip reader thatwirelessly transmits blood glucose information to the mobile device.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a block diagram of an infusion pump system in accordance withsome embodiments.

FIG. 2 is a schematic diagram of an infusion pump system including aperspective exploded view of an infusion pump assembly in accordancewith some embodiments.

FIG. 3 is a schematic diagram of the infusion pump system including aperspective assembled view of the infusion pump assembly in accordancewith some embodiments.

FIGS. 4A-C are a side views of the infusion pump system of FIGS. 2A-B inwhich the infusion pump assembly is worn on clothing of a user andoperated wirelessly in accordance with particular embodiments.

FIG. 5 is a flowchart of an example process for operating a medicaldevice with wireless communication capabilities in accordance with someembodiments.

FIG. 6 is a flowchart of an example process for using an infusion pumpassembly equipped with wireless communication capabilities in accordancewith some embodiments.

FIG. 6A is a flowchart of a first example process for determiningwhether a user as accepted a suggested bolus dosage.

FIG. 6B is a flowchart of a second example process for determiningwhether a user as accepted a suggested bolus dosage.

FIG. 6C is a flowchart of a third example process for determiningwhether a user as accepted a suggested bolus dosage.

FIG. 7 is a flowchart of an alternative example process for using aninfusion pump assembly equipped with wireless communication capabilitiesin accordance with some embodiments.

FIG. 8 is a flow chart of an example process for using a mobile deviceequipped with wireless communications capabilities in accordance withsome embodiments.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Referring to FIG. 1, an infusion pump system 10 can include an infusionpump assembly 20 and a mobile device 40, such as a smartphone deviceconfigured to connect with the internet and to execute mobileapplications. The pump assembly 20 and the mobile device 40 arecommunicatively coupled to one another. The pump assembly 20 isconfigured to controllably dispense dosages of medicine to be infusedinto the tissue or vasculature of a targeted individual, such as a humanor animal patient. For example, as described below, the infusion pumpassembly 20 can be used to deliver insulin or another medicinal fluidfor purposes of regulating the user's blood glucose levels. However,numerous other types of medicines can be used in some embodiments,including: pain relief drugs, hormone therapy, blood pressuretreatments, anti-emetics, osteoporosis treatments, or other injectablemedicines. As described below, the mobile device 40 can wirelesslycommunicate (e.g., via near field communication (NFC), Bluetoothconnectivity, or another short-range wireless connection, or via radiofrequency (RF) or Wi-Fi connectivity, or another wireless connection)with the pump assembly 20 to facilitate remote control of the pumpassembly 20 by a user operating the mobile device 40.

In this embodiment, the pump assembly 20 includes a wirelesscommunication device 21, a user interface 22, and a controller 23. Thewireless communication device 21 is operable to send and receive datasignals (e.g., discrete data packets or a continuous data stream) to andfrom a corresponding wireless communication device 41 of the mobiledevice 40. For example, the wireless communication device 21 may receivea trigger signal from the wireless communications device 41 of themobile device 40 to initiate a suggested dosage of medicine. The userinterface 22 can be engaged by a user to control the operation of thepump assembly 20. For example, in some embodiments, the user can engagethe user interface 22 to confirm acceptance, decline acceptance, ormodify a dosage of medicine suggested by the mobile device 40.

The controller 23 is operable to generate control signals that aretransmitted to various other components of the pump assembly 20, and toreceive feedback signals from one or more of those components. Thecontroller 23 includes a memory 24 that stores data andcomputer-readable instructions for processing/execution by a processor25. The processor 25 receives program instructions and feedback datafrom the memory 24, executes logical operations called for by theprogram instructions, and generates command signals for operating thevarious components of the pump assembly 20. For example, the controller23 can cause a suggested dosage received by the wireless communicationdevice 21 to be presented to the user via the user interface 22 (e.g.,by display or audible speech output). Further, the controller 23 cancause a drive system 26 of the pump assembly 20 to dispense thesuggested dosage of medicine from the medicine reservoir 27. Thecontroller is electrically powered by a battery 28.

In some embodiments, the medicine reservoir 27 can be provided in theform of a pre-filled cartridge slidably received within a housing of thepump assembly 20. In such embodiments, the drive system 26 can advance aplunger into the reservoir 27 so as to dispense medicine therefrom,which causes the medicine to be dispensed through tubing 29 of aninfusion set. As described in more detail below, the medicine reservoir27 can be received within a cavity in the infusion pump assembly 20. Insome embodiments, the reservoir 27 is a replaceable reservoir such that,when the replaceable reservoir is exhausted, the replaceable reservoircan be removed from the infusion pump assembly 20 and replaced withanother new pre-filled reservoir. In other embodiments, the reservoir 27may be non-removably received in the pump assembly 20 such that, whenthe medicine reservoir 27 is exhausted, the portion of the pump assembly20 that retains reservoir 27 is discarded along with the reservoir 27(refer, for example, to FIG. 2). For example, as described in moredetail below, the infusion pump assembly 20 may optionally comprisemultiple readily detachable portions, with various components of theinfusion pump assembly 20 residing in different detachable portions. Inone example described in FIG. 2 below, at least the controller 23, theuser interface 22, and the wireless communication device 21 can becontained within a first (reusable) detachable portion while the drivesystem 26, and the medicine reservoir 27 are contained within a second(disposable, single-use) detachable portion.

In some optional embodiments, the pump assembly 20 may further include aNFC circuit 30 responsive to an optional NFC circuit 46 incorporated inthe mobile device 40. NFC provides particularly short-range wirelesscommunication. In some embodiments, the maximum working distance for NFCis less than 12 inches, about 8 inches or less, and about 4 inches orless. NFC allows sharing of relatively small packets of data betweendevices equipped with NFC functionality. In some embodiments, wirelessNFC data transmission can be a two-way wireless communication. In otherwords, two interfacing NFC circuits can pass data packets back and forthbetween one another. The data communicated via NFC can be written in avariety of formats. One example format is called the NFC Data ExchangeFormat (“NDEF”). The NFC circuit 30 of the pump assembly 20 can beimplemented as a separate structure from the wireless communicationdevice 21, or can be implemented as part of the wireless communicationdevice 21. Likewise, the NFC circuit 46 of the mobile communicationsdevice 40 can be implemented as a separate structure from the wirelesscommunication device 41, or can be implemented as part of the wirelesscommunication device 41.

Further, although one or more embodiments described herein involve NFCcommunication via two intercommunicating NFC circuits, various otherembodiments may incorporate one or more NFC tags. For example, the NFCcircuit 46 of the mobile device could be replaced by an NFC tag. An NFCtag can store about a kilobyte of data or less, although NFC tags thatstore a greater quantity of data can also be used in the embodimentsdescribed herein. The NFC tags can be configured with a shape that issmall and lightweight (e.g., a maximum dimension of about 1 inch orless), particular because the NFC tags described the embodiment of FIG.1 do not have an integral power source such as a battery. Instead, acoil in the NFC tag inductively receives magnetic field energy that isemitted from a coil in NFC circuit housed in the portable infusion pump66. Accordingly, energy and data can be wirelessly transmitted betweenthe coils of the NCF tag and the device with NFC functionality.

The NFC circuits 30 and 46 may facilitate particularly short-rangewireless communications between the pump assembly 20 and the mobiledevice 40 when the NFC circuits 30 and 46 are in a NFC proximity range.The NFC circuit 30 can be electrically connected with the controller 23to transfer data communicated by the corresponding NFC circuit 46 of themobile device 40 to the controller 23. The NFC proximity range may bepreferably within a range four inches or less, including for example, aphysical “bump” between the pump assembly 20 and the mobile device 40.In some embodiments, the NFC circuit 30 can communicate data to thecontroller 23 indicating that the user has confirmed acceptance of asuggested medicine dosage provided by the mobile device 40. For example,as described in detail below, the user can bump the mobile device 40against the pump assembly 20 to confirm that the suggested medicinedosage is accepted by the user and therefore should be dispensed (FIGS.4C and 6B).

In some optional embodiments, the pump assembly 20 may include at leastone accelerometer 31 electrically connected with the controller 23. Insome embodiments, feedback from the accelerometer 31 (or from a set ofaccelerometers) can be used by the controller 23 to execute NFCcommunications when accelerated movement at or above the threshold levelis detected. Further in some embodiments, the controller 23 can utilizemovement information provided by the accelerometer 31 as independentdetection of a bump between the pump assembly 20 and the mobile device40.

The mobile device 40 includes the wireless communications device 41, theNFC circuit 46, or both so as to facilitate communications with the pumpassembly 20 (as described above) and a user interface 42 to facilitateuser operation of the mobile device 40. The wireless communicationsdevice 41 and the user interface 42 are electronically coupled to acontroller 43 that controls and receives feedback data from the variouscomponents (including the accelerometer 45 and the NFC circuit 46) ofthe mobile device 40. As noted above, the mobile device 40 canfacilitate remote operation of the pump assembly 20. For example, a usercan input an insulin dosage (e.g., a bolus dosage or a temporary basalrate dosage) to the controller 43 via the user interface 42, and thecontroller 43 can cause the wireless communications device 41 totransmit a data signal including the suggested dosage to the pumpassembly 20. As shown, the controller 43 includes a dosage calculatorapplication 44 provided in the form of computer-readable softwareprogram instructions configured, in this example, to calculate asuggested dosage of medicine based upon data related to the user's bloodglucose level. The calculated dosage can also be communicated wirelesslyto the pump assembly 20 (refer, for example, to FIG. 6).

In some embodiments, the infusion pump system 10 may optionally includea glucose monitoring device 50 a and/or a blood glucose test stripreader 50 b that communicate(s) with the mobile device 40 (e.g., via thewireless communication device 41) for the purpose of supplying dataindicative of a user's blood glucose level to the controller 43. Asnoted above, the dosage calculator application 44 can utilize the dataindicative of a user's blood glucose level in the calculation of adosage. For example, the dosage calculator application 44 can calculatethe recent rate of change in the user's blood glucose level and can usethis rate-of-change information as a parameter in the calculation of asuggested bolus dosage of insulin (or another medication) for the user.

In some embodiments, the dosage calculator application 44 can beconfigured to determine basal rate dosages of insulin (or anothermedication) along with user-initiated bolus dosages. The basal deliveryrate can be determined so as to maintain a user's blood glucose level ina targeted range during normal activity when the user is not consumingfood items. The user-selected bolus deliveries may provide substantiallylarger amounts of insulin in particular circumstances in which theuser's blood glucose level requires a significant correction or when theuser has recently consumed (or is about to consume) food items. In someembodiments, the dosage calculator application 44 can determine a bolusdosage for the user in a manner that accounts for some of all of: theuser's food intake, the user's recent blood glucose level (e.g., inputby the user via the user interface 42, or received from the glucosemonitoring device 50 a or the blood glucose test strip reader 50 b), therate of change in the user's blood glucose level, and previouslydelivered insulin that has not acted on the user. For example, a usercan enter a carbohydrate value indicative of a meal into the mobiledevice 40 via the user interface 42, and in response thereto, the dosagecalculator application 44 can calculate a suggested bolus dosage, whichis wireless communicated to the infusion pump assembly 20 (which thenawaits confirmation from the user for purposes of additional securityand accuracy).

For example, when a suggested dosage of medicine is calculated by thedosage calculator application 44, the controller 43 can cause thesuggested dosage to be communicated to the pump assembly 20 by thewireless communication device 41 (or by the NFC communication circuit46). The wireless communication device 21 (or the NCF circuit 30) of thepump assembly 20 can receive information indicative of the suggesteddosage, and the controller 23 can cause the suggested dosage to bepresented to the user via the user interface 22, with a prompt for theuser to accept or reject the dosage amount for dispensation. If the useraccepts the recommended dosage, the controller 23 can generate controlsignals to cause the drive system 26 to dispense the suggested dosage ofglucagon from the medicine cartridge 27. If the user rejects therecommended dosage, the controller 23 can provide the user with anoption to modify the dosage amount to a value different from thesuggested dosage or to reject any bolus dosage at the present time.

Referring now to FIGS. 2-3, some embodiments of the infusion pumpassembly 20 includes a pump device 100 and a removably attachablecontroller device 200 that are used together for purposes of supplyinginsulin or another medication to a user. Also, in this embodiment of thesystem 10, the mobile device 40 is provided in the form of a smartphonedevice configured to connect with the internet and to execute mobileapplications. As described above with reference to FIG. 1, thesmartphone device 40 receives data indicative of a user's blood glucoselevel from the glucose monitoring device 50 a and the blood glucose teststrip reader 50 b. In this embodiment, the smartphone device 40 isdepicted as executing an example implementation of the dosage calculatorapplication 44 (FIG.1) that utilizes the data indicative of a user'sblood glucose level in the calculation of a dosage.

Similar to the embodiment of FIG. 1, the smartphone device 40 includesthe wireless communication device 41 and the controller 43 executing thedosage calculator application 44. The smartphone device 40 furtherincludes at least one accelerometer 45 and the NFC circuit 46. In thisembodiment, the user interface 42 of the smartphone 40 includes atouchscreen 47 and at least one button 48, and the user interface 42 isconfigured to allow a user to remotely control the infusion pumpassembly 20. As described below, the user interface 42 may includevarious other components, e.g., one or more biometric recognitionsensors and/or face recognition hardware). In various alternativeembodiments, the mobile device 40 can be other types of devices such asa tablet computer, laptop computer, a PDA, a custom remote devicemanufactured specifically for interfacing with the pump assembly 20, andthe like.

Still referring to FIGS. 2-3, the glucose monitoring device 50 a caninclude a housing 51, a wireless communication device 52, and a sensorelement 53. The wireless communication device 52 can be contained withinthe housing 51 and the sensor element 53 can extend outward from thehousing 51. In use, the sensor element 53 can penetrate the skin surfaceof a user to make measurements indicative of characteristics of theuser's blood (e.g., the user's blood glucose level or the like). In someembodiments, the glucose monitoring device 50 a can include one or moreelectronic circuits that permit sensor signals (e.g., data from thesensor element 53) to be communicated to the communication device 52.Thus, in response to the measurements made by the sensor element 53, theglucose monitoring device 50 a can employ the wireless communicationdevice 52 to transmit data to the mobile device 40 via its wirelesscommunication device 41.

In some embodiments, the monitoring device 50 a can employ other methodsof obtaining information indicative of a user's blood characteristics.For example, an alternative monitoring device may employ a microporesystem in which a laser porator creates tiny holes in the uppermostlayer of a user's skin, through which interstitial glucose is measuredusing a patch. Alternatively, the monitoring device can useiontophoretic methods to non-invasively extract interstitial glucose formeasurement. In other examples, the monitoring device can includenon-invasive detection systems that employ near IR, ultrasound orspectroscopy, and particular embodiments of glucose-sensing contactlenses. Invasive methods involving optical means of measuring glucosecould also be added. In yet another example, the monitoring device caninclude an optical detection instrument that is inserted through theskin for measuring the user's glucose level.

The blood glucose test strip reader 50 b can include a housing 54, awireless communication device 55, a test-strip port 56, and a userinterface 57 including a display 58 and user-selectable buttons 59. Inuse, a user can deposit a test strip carrying a blood sample into thetest-strip port 56. The blood glucose test strip reader 50 b can analyzethe test strip and present data indicative of characteristics of theuser's blood (e.g., the user's blood glucose level or the like) on thedisplay 58. In some embodiments, the blood glucose test strip reader 50b can include one or more electronic circuits that permit sensor signals(e.g., data from the test-strip port 56) to be communicated to thecommunication device 55. Thus, using the user-selectable buttons 59, theuser can cause the wireless communication device 55 to transmit the datato the mobile device 40 via its wireless communication device 41.

It should be understood that in some alternative embodiments, theglucose monitoring device 50 a and the blood glucose test strip reader50 b may be operable to communicate data indicative of characteristicsof the user's blood by a wired connection. Further, in some embodiments,such data can be entered directly into the mobile device 40 via the userinterface 42.

In some embodiments, the controller device 200 of the infusion pumpassembly 20 is equipped with wireless communication capabilities, andthe controller device 200 is configured to mechanically mount togetherwith the removable pump device 100 (exploded view shown in FIG. 2) so asto electrically communicate with the pump device 100. The pump device100 in this embodiment includes a housing structure 110 that defines acavity 116 in which a fluid cartridge 120 can be received. The pumpdevice 100 can also include a cap device 130 to retain the fluidcartridge 120 in the cavity 116 of the housing structure 110. The pumpdevice 100 can include a drive system 140 that advances a plunger 125 inthe fluid cartridge 120 so as to dispense fluid 126 therefrom. In someembodiments, the dispensed fluid exits the fluid cartridge, passesthrough a flexible tube 72 of an infusion set 70 to a cannula housing 74retained to the user's skin by a skin adhesive patch 78 (FIG. 3). Thedispensed fluid can enter through the skin via a cannula 76 attached tothe underside of the cannula housing 74 (FIG. 3).

In some embodiments, the controller device 200 communicates with thepump device 100 to control the operation of the drive system 140. Whenthe controller device 200, the pump device 100 (including the cap device130), and the fluid cartridge 120 are assembled together, the user can(in some embodiments) conveniently wear the infusion pump assembly 20 onthe user's skin under clothing, in a pouch clipped at the waist (e.g.,similar to a cell phone pouch), or in the user's pocket while receivingthe fluid dispensed from the pump device 100 (see FIGS. 4A-C).Optionally, the controller device 200 may be configured as a reusablecomponent that provides electronics and a user interface to control theoperation of the pump device 100. In such circumstances, the pump device100 can be a disposable component that is disposed of after a singleuse. For example, the pump device 100 can be a “one time use” componentthat is thrown away after the fluid cartridge 120 therein is exhausted,and the pump device 100 can be equipped with one or more structures thatphysically hinder reuse of the pump device 100 with a subsequentcartridge 120 (e.g., such as one or more anchors that penetrate andretain the medicine cartridge 120 to hinder removal, the cap device 130being non-reversibly attached to the pump housing 110, or the like).Thereafter, the user can removably attach a new pump device 100 (havinga new medicine cartridge 120) to the reusable controller device 200 forthe dispensation of fluid from a new fluid cartridge 120. Accordingly,the user is permitted to reuse the controller device 200 (which mayinclude complex or valuable electronics, as well as a rechargeablebattery) while disposing of the relatively low-cost pump device 100after each use. Such a pump assembly 20 can provide enhanced user safetyas a new pump device 100 (and drive system therein) is employed witheach new fluid cartridge 120.

Briefly, in use, the pump device 100 is configured to removably attachto the controller device 200 in a manner that provides a secure fitting,an overall compact size, and a reliable electrical connection that canbe resistant to water migration. For example, the controller device 200can include a housing 210 having a number of features that mate withcomplementary features of the pump housing structure 110. In suchcircumstances, the controller device 200 can removably attach with thepump device 100 in a generally side-by-side configuration. The compactsize permits the infusion pump assembly 20 to be discrete and portable.Moreover, at least one of the pump device 100 or the controller device200 can include a release member that facilitates an easy-to-usedetachment and replacement process.

As shown in FIG. 2, the pump device 100 can include an electricalconnector 118 (e.g., having conductive pads, pins, and the like) that isexposed to the controller device 200 and that mates with a complementaryelectrical connector (not shown) on the adjacent face of the controllerdevice 200. The electrical connection between the pump device 100 andthe controller device 200 provides the electrical communication betweenthe control circuitry housed in the controller device 200 and at least aportion of the drive system 140 or other components of the pump device100. For example, in some embodiments, the electrical connection betweenthe pump device 100 and the controller device 200 can permit thetransmission of electrical control signals to the pump device 100 andthe reception of feedback signals (e.g., sensor signals) from particularcomponents within the pump device 100. The electrical connection betweenthe pump device 100 and the controller device 200 may similarlyfacilitate transmission of one or more power signals for sharingelectrical power therebetween.

The pump device 100 may include a drive system 140 that is controlled bythe removable controller device 200. Accordingly, the drive system 140can accurately and incrementally dispense fluid from the pump device 100in a controlled manner. The drive system 140 may include a flexiblepiston rod 141 that is incrementally advanced toward the medicinecartridge 120 so as to dispense the medicine from the pump device 100.At least a portion of the drive system 140 is mounted, in thisembodiment, to the pump housing structure 110. In some embodiments, thedrive system 140 may include a number of components, such as anelectrically powered actuator (e.g., reversible motor 142 or the like),a drive wheel 143, a bearing 145, the flexible piston rod 141, and aplunger engagement device 144. In this embodiment, the reversible motor142 drives a gear system to cause the rotation of the drive wheel 143that is coupled with the bearing 145. The drive wheel 143 may include acentral aperture with an internal thread pattern, which mates with anexternal thread pattern on the flexible piston rod 141. The interface ofthe threaded portions of the drive wheel 143 and flexible piston rod 141may be used to transmit force from the drive wheel to the piston rod141. Accordingly, in the embodiment of FIG. 2, the drive wheel 143 isthe driver while the flexible piston rod 141 is the driven member. Therotation of the drive wheel 143 can drive the flexible piston rod 141forward in a linear longitudinal direction to cause the plungerengagement device 144 to nudge the plunger 125 within the fluidcartridge 120 so as to dispense fluid 126 therefrom.

Still referring to FIG. 2, the controller device 200 can include a userinterface 222 that permits a user to monitor and control the operationof the pump device 100. In some embodiments, the user interface 222 caninclude a display device 223 and one or more user-selectable buttons(e.g., several buttons 224 including buttons 224 a and 224 b are shownin the embodiment of FIG. 2). Additionally or alternatively, the userinterface 222 can include a touchscreen display device. The displaydevice 223 can include an active area in which numerals, text, symbols,images, or a combination thereof can be displayed. For example, thedisplay device 223 can be used to communicate a number of settings ormenu options for the infusion pump assembly 20. In this embodiment, theuser may press one or more of the buttons 224 to shuffle through anumber of menus or program screens that show particular settings anddata (e.g., review data that shows the medicine dispensing rate, thetotal amount of medicine dispensed in a given time period, the amount ofmedicine scheduled to be dispensed at a particular time or date, theapproximate amount of medicine remaining in the cartridge 120, or thelike). In some embodiments, the user can adjust the settings orotherwise program the controller device 200 by pressing one or morebuttons 224 of the user interface 222. For example, in embodiments ofthe infusion pump assembly 20 configured to dispense insulin, the usermay press one or more of the buttons 224 to change the dispensation rateof insulin or to request that a bolus of insulin be dispensedimmediately or at a scheduled, later time. In some implementations, thedisplay device 223 may also be used to communicate information regardingremaining battery life. Further, in this embodiment, the user can acceptor decline a suggested dosage of medicine by pressing either of buttons224 a and 224 b of the user interface 222.

The controller device 200 can also be equipped with an inspection lightdevice 228. The inspection light device 228 can provide the user with atool to illuminate and inspect a targeted location. For example, theinspection light device 228 can be directed at the infusion site on theuser's skin to verify that the infusion set is properly embedded, or theinspection light device 228 can be directed at the pump device 100 toilluminate the cavity 116 or other areas. The inspection light device228 can also be used to notify the user to an alert condition of thepump assembly 20. An activation of the inspection light device 228 canthereby provide a visual notification (as an alternative to, or inaddition to, the visual notification provided on the display device 223)to the user that attention to the infusion pump assembly 20 iswarranted.

The controller device 200 of the pump assembly 20 also includes awireless communication device 221, an NFC circuit 230, and anaccelerometer 231. Each of these components can be in electricalcommunication with the control circuitry of the controller device 200.The wireless communication device 221 can facilitate wirelesscommunications between the pump assembly 20 and the mobile device 40. Asnoted above, the wireless communication device 221 can send and receivedata signals to and from the corresponding wireless communication device41 of the mobile device 40 via a short-range wireless connection (e.g.,RF, Wi-Fi, or Bluetooth connectivity). For example, the controllerdevice 200 can receive a trigger signal to initiate a bolus dosage ofinsulin from the mobile device 40 via the communication devices 221 and41.

In some embodiments, wireless communications between the controllerdevice 200 and the mobile device 40 can incorporate one or more securitymeasures to inhibit signal hijacking. As one example, a securecommunications protocol involving security-coded wireless data packetscan be implemented in wireless communications between the controllerdevice 200 and the mobile device 40. As another example, the controllerdevice 200 and the mobile device 40 can execute a wireless pairingroutine to establish a one-to-one wireless connection. In someembodiments, the pairing may involve an exchange of unique informationrelating to the user (e.g., a passcode established by the user) of thedevices.

In some embodiments, the trigger signal can include a suggested dosageamount. The suggested dosage amount can be determines by a dosagecalculator application 44 executed by a controller 43 of the mobiledevice 40. In some embodiments, the dosage calculator application 44determines the suggested dosage amount based on data indicative of auser's blood glucose level received from the glucose monitoring device50 a or the blood glucose test strip reader 50 b. In some embodiments,the dosage calculator application 44 also utilizes data indicative ofthe rate of change in the user's blood glucose level and/or dataindicative of the user's food consumption in determining the suggestedmedicine dosage amount.

In this example, the dosage calculator application 44 determines asuggested bolus dosage of insulin of 4.0 units. The suggested bolusdosage is presented to the user via the touchscreen 47 of the userinterface 42. The user can accept or decline the suggested bolus dosageby interacting with the user interface 42 (e.g., by selecting the “YES”or “NO” option on the touchscreen 47). If the user accepts the suggestedbolus dosage, the wireless communication device 41 can transmit atrigger signal to initiate the suggested bolus dosage to the controllerdevice 200 of the pump assembly 20. The wireless communication device221 of the controller device 200 can receive the trigger signal. Thecontroller device 200 can provide a notification to the user indicatingthat a suggested bolus dosage has been received. The notification can bevisual, audible, tactile, and a combination thereof. For instance, asdepicted in this embodiment, the controller device can present thesuggested bolus dosage to the user via the display device 223.

In some embodiments, the controller device 200 is configured to wait forconfirmation at the pump assembly 20 that the suggested bolus dosage isacceptable to the user before initiating dispensation. As discussedbelow with reference to FIGS. 4A-C, user confirmation at the pumpassembly 20 of an accepted bolus dosage may be provided in a variety ofways. If the user confirms acceptance of the bolus dosage via the userinterface 222, the controller device 200 can cause the pump device toinitiate dispensation of the suggested bolus dosage. In someembodiments, the controller device 200 may transmit a confirmationsignal to the mobile device 40 to indicate that the suggested bolusdosage has been initiated. In some embodiments, if the user declines orchooses to modify the suggested bolus dosage, the controller device 200may transmit a signal to the mobile device 40 to indicate the rejectionor modification.

Referring to FIGS. 4A-C, in some embodiments, the infusion pump assembly20 is pocket-sized so that the pump device 100 and controller device 200can be worn in the user's pocket 6 or in another portion of the user'sclothing. For example, the pump device 100 and the controller device 200can be attached together and form the pump assembly 20 that comfortablyfits into a user's pocket 6. The user can carry the portable infusionpump assembly 20 and use the tube 72 of the infusion set 70 to directthe dispensed medicine to the desired infusion site. In somecircumstances, the user may desire to wear the pump assembly 20 in amore discrete manner. Accordingly, the user may pass the tube 72 fromthe pocket 6, under the user's clothing, and to the infusion site wherethe adhesive patch 78 is positioned. As such, the pump system 10 can beused to deliver medicine to the tissues or vasculature of the user in aportable, concealable, and discrete manner. Furthermore, the monitoringdevice 50 a can be worn on the user's skin while the pump assembly 20 iscarried by the user (e.g., in a pocket). As such, the monitoring device50 a can communicate information indicative of the user's blood glucoselevel to the pump assembly 20 via a wireless connection while the pumpassembly 20 is used to deliver medicine through the infusion set 70. Inthis embodiment, the monitoring device 50 a may be arranged on theuser's skin at a location that is spaced apart from the infusion set 70.

FIG. 4A depicts a first user confirmation technique, where the userinterfaces directly with the pump assembly 20. In this example, the usercan respond to an alert (e.g., an audible chime or a vibration) from thepump assembly 20 indicating that a suggested bolus dosage has beenreceived by removing the pump assembly 20 (at least the controllerdevice 200 if detachable) from his/her pocket 6 and engaging the userinterface 222 of the controller device 200. In some embodiments, theuser can confirm acceptance, decline acceptance, or request amodification of the suggested bolus dosage via the user-selectablebuttons 224 of the controller device 200. In response to receiving theconfirmation of acceptance, the pump assembly 20 can initiatedispensation of the suggested bolus dosage.

FIG. 4B depicts a second user confirmation technique, where the userinterfaces directly with the mobile device 40. In this example, the usercan respond to the alert from the pump assembly 20 by engaging the userinterface 42 of the mobile device 40. In some embodiments, the user canconfirm acceptance, decline acceptance, or request a modification of thesuggested bolus dosage via the user interface 42 (e.g., by selecting anappropriate option presented on the touch screen 47). In someembodiments, the user may be prompted to enter a security code toconfirm acceptance of the suggested bolus dosage. In some embodiments,the user may be prompted to provide a biometric confirmation ofacceptance, e.g., a fingerprint or facial recognition, via the userinterface 42. In response to receiving the confirmation of acceptance,the mobile device 40 can transmit a confirmation signal to the pumpassembly 20 to initiate dispensation of the suggested bolus dosage.

FIG. 4C depicts a third user confirmation technique, where the user canprovide confirmation of an accepted suggested bolus dosage (wirelesslycommunicated from the mobile device 40 to the pump assembly 20) withoutdirectly viewing the pump assembly 20. In this embodiment, the user canrespond to the alert from the pump assembly 20 by physically bumping themobile device 40 against the pump assembly 20 (optionally, with one ormore layers of clothing therebetween) while the pump assembly 20 remainsin the user's pocket 6. As described below in connection with FIG. 6B,the pump assembly 20 can detect the bump and initiate dispensation ofthe suggested bolus dosage.

In some embodiments, the pump assembly 20 can detect a bump with themobile device 40 via the NFC circuit 230 and/or the accelerometer 231.As one example, the bump from the mobile device 40 against the pumpassembly (e.g., directly or indirectly such that both devices undergo adetectable bump impact) can cause a simultaneous data exchange betweenthe NFC circuit 230 integrated in the controller device of the pumpassembly 20 and the NFC circuit 46 in the mobile device 40. The dataexchange may provide a confirmation signal to the pump assembly 20indicating that the user has confirmed acceptance of the suggested bolusdosage. In some embodiments, the accelerometers 231 (in the pumpassembly 20) and 45 (in the mobile device 40) can operate in conjunctionwith the NFC circuit 230 to supplement the criteria for activatingcommunications between the NFC circuits 230 and 46. In other words,while in some embodiments, NFC communications are initiated based merelyon proximity between the NFC circuits 230 and 46, in other embodiments athreshold movement of the pump assembly 20 and/or the mobile device 40must be detected to activate NFC communication. An objective forincluding this feature can be to more clearly ascertain that the userdesires to accept the suggested bolus dosage via NFC when the NFCcircuits 230 and 46 are in range of one another. That is, by requiringthe user to physically bump the mobile device 40 against the pumpassembly 20, the user's intentions for accepting the suggested bolusdosage can be confirmed with a greater level of confidence.

In some embodiments, this optional feature of using the accelerometer231 in conjunction with the NFC circuit 230 can function as follows.When a movement is detected by accelerometer 231, the characteristics ofthe movement can be compared by to a predetermined threshold value(e.g., a threshold movement indicative of the aforementioned “bump” ortap movement). If the detected movement is greater than or equal to thethreshold value, the NFC circuit 230 can potentially be activated. But,if no movement that is greater than or equal to the threshold value isdetected, the NFC circuit 230 is not activated (even if the NFC circuit230 is within the required proximity of the NFC circuit 46 such that NFCcommunications can potentially be performed). Therefore, in someembodiments this feature operates to enable NFC when the following twoconditions are simultaneously met, or are both met within an establishtime interval: (i) an acceleration or an acceleration profile that isgreater than or equal to a threshold value is detected (indicating,e.g., a tap or other “bump” action between the pump assembly 20 and themobile device 40), and (ii) the NFC circuit 230 is in proximity with theNFC circuit 465 such that communications therebetween using NFC canoccur. In some embodiments, the accelerometer 45 can be similarlyoperated in conjunction with the NFC circuit 46 of the mobile device 40.

In some embodiments, the accelerometers 231 and 45 can be used to detecta bump independently of the NFC circuits 230 and 46. For example, thepump assembly 20 can detect the bump by sensing a movement via theaccelerometer 231 and receiving bump confirmation signal from the mobiledevice 40 via the wireless communication devices 221 and 41. In someembodiments, the bump confirmation signal must be received within apredetermined time window (e.g., about 0.5 seconds to about 2 seconds)to be considered a detectable bump by the pump assembly 20. In someembodiments, the pump assembly 20 is configured to delay dispensationuntil a pattern of bumps (e.g., two or more bumps) is detected. Thisfeature may reduce the likelihood of inadvertent acceptance of thesuggested bolus dosage by a false-positive bump. In some embodiments,the NFC circuits 230 and 46 can communicate a unique identifier (e.g., aserial number) to one another as a security code to establish aone-to-one NFC connection. This feature may reduce the likelihood of aninadvertent acceptance of the suggested bolus dosage, for example, ifthe user accidently bumps his/her infusion pump assembly into anotheruser's mobile device.

In some embodiments, as similar bump technique for NFC as describedabove for user-confirmation of an accepted bolus dosage can be used tosend the original trigger signal (described above as being implementedby short range wireless communication). For example, a suggested dosagedetermined by the dosage calculator application 44 could be coded intothe NFC circuit 46 of the mobile device 40 and transmitted by anNFC-bump to the NFC circuit 230 (and therefore the control circuitry) ofthe pump assembly 20.

Referring now to FIG. 5, the control circuitry of a medical device(e.g., an infusion pump assembly) that includes wireless communicationequipment can implement a process 500 of receiving commands from amobile device, and controlling the medical device in accordance withreceived commands. Such a process 500, for example, can be implementedby the control circuitry housed in the controller device 200 of aninfusion pump assembly 20 (FIGS. 2-3). However, this document is notnecessarily limited to any particular medical device with respect toprocess 500.

In operation 510, the control circuitry of a medical device can receiveinput via wireless communication from a mobile device (e.g., asmartphone). The input can be indicative of a task associated with usingthe medical device. A medical device that can perform operation 510 isexemplified in FIGS. 2-3, where a wireless communication device 221 andan NFC circuit 230 are in electrical communication with the controlcircuitry of a controller device 200 of an infusion pump assembly 20. Asexplained above, the wireless communication device 221 and the NFCcircuit 230 of the pump assembly 20 can function to receive and sendcommunications from a corresponding wireless communication device 41 andNFC circuit 46 of the mobile device 40. An example of operation 310 isprovided in FIGS. 2-3, where dosage calculator application 44 of themobile device 40 determines a suggested bolus dosage of insulin (oranother medication) and transmits a trigger signal to the pump assembly20 via the wireless communication devices 41 and 221.

In operation 520, the control circuitry optionally provides a prompt forthe user to confirm a change in the operation of the medical device inresponse to input received from the mobile device. Such a prompt may beadvantageously used to confirm the user's intent to change the operationof the medical device before the control circuitry actually implementsthe change. An example of operation 520 is provided in FIGS. 2-3, wherethe control circuitry of the controller device 200 of the pump assembly20 generated the illustrated textual prompt on the display 223. Theprompt provides a description of the potential change in operation(“Bolus Initiated from Mobile Device; Deliver Requested Bolus? 4.00Units”). Alternatively or additionally, other techniques can be used forprompting the user to confirm the user's intent to change the operationof the medical device. For example, the medical device can provide avisual (e.g., a flashing light), auditory (e.g., a chime) and/or tactile(e.g., vibration) alert. As described above, by pressing a button 224 aof the user interface 222, the user can confirm the user's intent toimplement a change in the operation of the infusion pump assembly 20. Asdescribed in connection with FIGS. 4A-C, the user can provideconfirmation by interacting directly with the pump assembly 20 and/orthe mobile device 40 via a user interface, or by bumping the mobiledevice against the pump assembly 20. In some embodiments, the userconfirmation techniques of FIGS. 4A-C can be modified or combined toachieve an acceptable level of security and reliability.

In operation 530, after receiving confirmation from the user toimplement the change associated with the input from the mobile device,the control circuitry can control the medical device to change theoperation of the medical device in accordance with the user'sconfirmation of the change. Again in regard to the example of FIGS. 2-3,when the user confirms the change to the infusion pump assembly 20related to the suggested bolus dosage, the control circuitry of thecontroller device 200 can thereafter control the pump device 100 todeliver the corresponding bolus dispensation of insulin.

Referring now to FIG. 6, the infusion pump assembly 20 can dispense abolus dosage of medicine suggested by the mobile device 40 afterreceiving confirmation that the suggested bolus dosage is accepted bythe user. For example, a process 600 for dispensing a suggested bolusdosage can be implemented by the controller device 200 of the pumpassembly 20. In operation 605, the controller device 200 can wait for atrigger signal from the mobile device 40 to initiate a bolus dosage(e.g., a bolus dosage determined by the dosage calculator application44). The trigger signal may be received via short-range wirelesscommunication or NFC. In operation 607, the controller device 200 canoptionally validate the trigger signal. In some embodiments, validatingthe trigger signal may include detecting a signal strength of theshort-range wireless connection between the pump assembly 20 and themobile device 40, and comparing the signal strength to a predeterminedthreshold. The controller device 200 may only validate a trigger signalif the detected signal strength is greater than the threshold. Anobjective for this feature can be to verify that the mobile device 40 isclose in proximity to the pump assembly 20, which increases thereliability that the trigger signal originated from a mobile device inthe user's possession. In some embodiments, validating the triggersignal may include applying a unique decryption key to trigger signalthat has been encrypted.

In operation 610, the user is prompted to accept the suggested bolusdosage indicated by the trigger signal. At operation 615, the controllerdevice 200 determines if the user accepts the suggested bolus dosage. Inoperation 620, if the user accepts the suggested bolus dosage (615), thecontroller device 200 initiates delivery of the suggested bolus dosagevia the pump device 100. If the user declines the suggested bolus dosage(615), the controller device 200 can prompt the user for a modifiedbolus dosage (e.g., via a prompt script provided on the display device223). In operation 625, the controller device determines if the userwishes to receive a modified bolus dosage. In operation 630, if the userwishes to receive a modified bolus dosage (625), the controller device200 can obtain the modified bolus dosage amount via the user interfaceelements (e.g., the user-selectable buttons 224). And in operation 635,the controller device 200 can initiate delivery of the modified bolusdosage via the pump device 100. At operation 637, the controller device200 can optionally provide a confirmation signal indicative of aninitiated bolus delivery. For example, the controller device 200 canprovide a visual, auditory, or tactile alert perceptible by the userand/or transmit a confirmation signal to the mobile device 40. After asuggested (620) or modified (635) bolus dosage is initiated, or afterthe suggested (615) and modified (625) dosages have been declined by theuser, the process 600 can return to operation 605, where the controllerdevice 200 can wait for a subsequent trigger signal to initiate anotherbolus dosage.

Revisiting operation 615, FIG. 6A depicts a first example sub-process615 a executable by the controller device 200 for determining whetherthe user accepts the suggested bolus dosage. In operation 640, thecontroller device 200 can wait for a user-confirmation signal indicatingthat the user has accepted the suggested bolus dosage. In operation 645,the controller device can determine whether a user-confirmation signalhas been received via one or more user interface elements (e.g., theuser selectable buttons 624) of the user interface 222 within apredetermined time window (e.g., between about 0.5 seconds and about 15seconds). If the user-confirmation signal is not received within thetime window (645), the controller device 200 can determine that the userdoes not accept the suggested bolus dosage. If the user-confirmationsignal is received within the time window (645), the controller device200 can determine that the user does accept the suggested bolus dosage.An example of the sub-process 615 a is provided in FIGS. 2-3 and 4A,where the user-confirmation signal is received when the user selects thebutton 224 a corresponding to the “Accept” option presented on thedisplay device 223. If the user selects the button 224 a within thepredetermined time window, the controller device 200 can determine thatthe user accepts the suggested bolus dosage. However, if the user doesnot select the button 224 a within the predetermined time window, or ifthe user selects the button 224 b corresponding to the “Decline” option,the controller device 200 can determine that the user does not acceptthe suggested bolus dosage. In some embodiments, if the sub-process 615a times out (e.g., if the user confirmation signal is not received inthe predetermined time window), the controller device 200 may provide areminder alert to the user.

FIG. 6B depicts a second example sub-process 615 b executable by thecontroller device 200 for determining whether the user accepts thesuggested bolus dosage. In operation 650, the controller device 200 canwait for a user confirmation of the suggested bolus. In operation 655the controller device 200 can detect a bump event. In operation 660, thecontroller device 200 can receive a bump-confirmation signal from themobile device 40. In operation 665, the controller device 200 candetermine whether the bump-event confirmation signal was received withina predetermined time window (e.g., about 0.5 seconds to about 2 seconds)starting from the bump event detection. If the bump-confirmation signalis not received within the time window (665), the controller device 200can determine that the user does not accept the suggested bolus dosage.If the bump-confirmation signal is received within the time window(665), the controller device 200 can determine that the user does acceptthe suggested bolus dosage.

An example of the sub-process is provided FIG. 4C, where the controllerdevice 200 is described as operable to detect a bump event using NFCcommunication via an NFC circuit 230 of the controller device 200. Asyet another example described in connection with FIG. 4C, anaccelerometer 231 integrated with the control circuitry of thecontroller device 200 can detect movement indicative of a bump event. Ifthe mobile device 40 independently detects the bump event via its NFCcircuit 46 and/or accelerometer 45 it can transmit a bump-confirmationsignal the controller device 200. In some embodiments, e.g., when thebump event is detected via NFC communication, the bump-confirmationsignal may be received simultaneously with the bump event detection viatwo-way communication between the NFC circuits 230 and 46.

FIG. 6C depicts a third example sub-process 615 c executable by thecontroller device 200 for determining whether the user accepts thesuggested bolus dosage. In operation 670, the controller device cantransmit (e.g., via short-wireless connection or NFC connection) aconfirmation signal to the mobile device 40 indicating receipt of thesuggested bolus dosage via the trigger signal. In operation 675, thecontroller device 200 can wait for a user-confirmation signal indicatingthat the user has accepted the suggested bolus dosage. In operation 680,the controller device 200 can determine whether a user-confirmationsignal has been received from the mobile device 40 within apredetermined time window (e.g., between about 0.5 seconds and about 15seconds). If the user-confirmation signal is not received within thetime window (680), the controller device 200 can determine that the userdoes not accept the suggested bolus dosage. If the user-confirmationsignal is received within the time window (680), the controller device200 can determine that the user does accept the suggested bolus dosage.An example of the sub-process 615 a is provided in FIG. 4B, where theuser engages the user interface 42 of the mobile device 40 to confirmacceptance, decline acceptance, or request a modification of thesuggested bolus dosage. For example, in some embodiments, the user maybe prompted to provide a security code to confirm acceptance or abiometric confirmation of acceptance, e.g., a fingerprint or facialrecognition, via the user interface 42. If the user confirms acceptancevia the user interface 42 within the predetermined time window, thecontroller device 200 can determine that the user accepts the suggestedbolus dosage. However, if the user does not confirm acceptance using theuser interface 42 within the predetermined time window, or if the userdeclines the suggested bolus dosage (or request a modified dosage) usingthe user interface 42, the controller device 200 can determine that theuser does not accept the suggested bolus dosage.

Referring now to FIG. 7, an alternative process 700 for dispensing asuggested bolus dosage can be implemented by the controller device 200of the pump assembly 20. Operations 705-725 are similar to operations ofthe process 600. In operation 705, the controller device 200 can waitfor a trigger signal from the mobile device 40 to initiate a bolusdosage (e.g., a bolus dosage determined by the dosage calculatorapplication 44). The trigger signal may be received via short-rangewireless communication or NFC. In operation 710, the user is prompted toaccept the suggested bolus dosage indicated by the trigger signal. Inoperation 720, if the user accepts the suggested bolus dosage (715), thecontroller device 200 initiates delivery of the suggested bolus dosagevia the pump device 100. At operation 715, the controller devicedetermines if the user accepts the suggested bolus. If the user declinesthe suggested bolus dosage (715), the controller device can prompt theuser for a modified bolus dosage. At operation 737, the controllerdevice 200 can optionally provide a confirmation signal indicative of aninitiated bolus delivery. For example, the controller device 200 canprovide a visual, auditory, or tactile alert perceptible by the userand/or transmit a confirmation signal to the mobile device 40.

At operation 725, the controller device determines if the user wishes toreceive a modified bolus dosage. At operation 785, if the user wishes toreceive a modified bolus dosage (725), the controller device 200 cantransmit a signal to the mobile device 40 requesting a modified bolusdosage. In some embodiments, the mobile device 40 can prompt the user,e.g., via the user interface 42, to provide a modified dosage or toprovide new data for the dosage calculator application 44 to consider indetermining a suggested bolus dosage. After a suggested bolus dosage isinitiated (720) or declined (725), or after a modified dosage has beenrequested (785), the process can return to operation 705, where thecontroller device 200 can wait for a subsequent trigger signal toinitiate another bolus dosage.

Referring now to FIG. 8, the dosage calculator application 44 executedby the controller 43 of the mobile device 40 can determine a suggestedbolus dosage based on data indicative of the user's blood glucose level.For example, a process 800 for determining a suggested bolus dosage andproviding the suggested dosage to an infusion pump assembly 20 can beimplemented by the mobile device 40. As previously described, the pumpassembly 20 can operate to deliver insulin to the user by basal dosages,selected bolus dosages, or a combination thereof. A basal rate ofinsulin can be delivered in an incremental manner (e.g., dispense 0.25 Uevery fifteen minutes for a rate of 1.0 U per hour) to help maintain theuser's blood glucose level within a targeted range during normalactivity, when the user is not consuming food items. The user may selectone or more bolus deliveries, for example, to offset the blood glucoseeffects caused by food intake, to correct for an undesirably high bloodglucose level, to correct for a rapidly increasing blood glucose level,or the like. In some circumstances, the basal rate pattern may beprogrammed by a health care professional during a clinical visit (or,optionally, by the user) and may remain at a substantially constant ratefor a long period of time (e.g., a first basal dispensation rate for aperiod of hours in the morning, and a second basal dispensation rate fora period of hours in the afternoon and evening). In contrast, the bolusdosages can be dispensed in user-selected amounts based on calculationsmade by the dosage calculator application 44. For example, the dosagecalculator application 44 can determine that the user's blood glucoselevel is rapidly increasing (e.g., by interpreting data received fromthe glucose monitoring device 50 a and/or the blood glucose test stripreader 50 b, or the like) and can make a suggestion to the user toadminister a bolus of insulin to correct for the rapid increase in bloodglucose level. In another example, the user can request (via the userinterface 42) that the dosage calculator application 44 calculate andsuggest a bolus dosage based, at least in part, on a proposed meal thatthe user plans to consume.

The basal and bolus insulin dispensed into the user's system may actover a period of time to control the user's blood glucose level. Assuch, the user can benefit from the embodiments of the infusion pumpsystem 10 that can take into account different circumstances andinformation when determining the amount of a bolus dosage to suggest tothe user. For example, the dosage calculator application 44 may betriggered to suggest a bolus dosage in response to the user's input ofmeal information (See FIGS. 2-3). When calculating the bolus dosage,however, the user may benefit if the dosage calculator application 44employed information, in addition to the meal information, whencalculating the bolus dosage. In some embodiments, the dosage calculatorapplication 44 can use information such as data indicative of the user'sblood glucose level, food intake data recently submitted by the user viathe user interface 42 of the mobile device 40, the user's insulin load,and the like. Exemplary information that can be derived from the user'sblood glucose information that can be used by the dosage calculatorapplication 44 in determining a bolus dosage can include the user'scurrent blood glucose level, the rate of change in the user's bloodglucose level, the 2^(nd) derivative of the user's blood glucose data,the shape and/or appearance of the user's blood glucose curve, or thelike. In some embodiments, the dosage calculator application 44 can useinformation from previously entered meals and previously deliveredinsulin dosages when calculating a suggested bolus dosage. In theseembodiments, information regarding previously entered meals andpreviously delivered insulin dosages from 12 hours or more (e.g., 24hours, 12 hours, 8 hours, 6 hours, 0.5 hours, or the like) can be usedin the bolus dosage calculations.

In some embodiments, the controller device 200 may implement one or moreoperations of the process 800 (FIG. 8) to determine and suggest aninsulin bolus dosage which includes a food offsetting component, a bloodglucose correction component, and an insulin load correction component.The food offsetting component can represent an insulin bolus dosage tooffset food intake data that have not previously been offset by anearlier bolus dosage. The blood glucose correction component canrepresent an insulin bolus dosage to maintain or return the user's bloodglucose level to a targeted value within a predetermined range. Thiscomponent can be derived from data indicative of a user's blood glucoselevel such as the user's current blood glucose level and the recent rateof change in the user's blood glucose level. The insulin load correctioncomponent can take into account insulin that has been previouslyreceived and food that has been previously consumed, but has not actedon the user. For example, the delay between a subcutaneous delivery of abolus dosage of insulin and the peak plasma insulin level achieved fromthis bolus can be one hour or more. Additionally, the bolus dosage maynot enter the subcutaneous tissue all at once. As such, the effect ofthe bolus can peak at about one to two hours and then decay in apredictable manner over as much as eight hours or. Due to the time decayeffects of insulin activity, the user could be susceptible to request asubsequent bolus dosage while some insulin from a previously deliveredbolus dosage has not yet acted upon the user (a scenario sometimesreferred to as “bolus stacking”). To reduce the likelihood ofundesirable bolus stacking, the insulin load information can bedetermined by dosage calculator application 44 on a periodic basis sothat the user can be aware of the previously dispensed insulin which hasnot yet acted in the user's body. In a similar manner, food that hasbeen previously consumed does not instantaneously act on the user andhave its effects quickly decay. Depending on the type of food consumed,the effects of the food can be delayed and then slowly decay over time.In particular embodiments, the insulin load correction component maycorrect for the delayed effects of both previously delivered insulin andpreviously consumed food items.

Referring in more detail to FIG. 8, the illustrative process 800 fordetermining a suggested bolus dosage and providing the suggested dosageto an infusion pump assembly 20 can include a number of operationsperformed by various components of the mobile device 40. In operation405, the dosage calculator application 44 can wait for a trigger toinitiate a bolus dosage calculation. Exemplary triggers that can causethe dosage calculator application 44 to initiate a bolus dosagecalculation can include a user input of food intake data (e.g., via theuser interface 42 of the mobile device 40), an input of blood glucosedata (e.g., as measured and transmitted wirelessly by the glucosemonitoring device 50 a and/or the blood glucose test strip reader 50 b),a user request for a bolus dosage, the user's blood glucose levelexceeding a predetermined threshold level, the user's blood glucoselevel increasing at a high rate greater than a predetermined thresholdrate, or the like. In some embodiments, the suggested bolus dosage valuecan be calculated based on at least two of the three components aspreviously described: the food offsetting component, the blood glucosecorrection component, and the insulin load correction component. Itshould be understood from the description herein that the components canbe contemporaneously calculated to provide the suggested bolus dosagevalue or, alternatively, calculated in discrete steps and then combinedto provide the suggested bolus dosage value.

In operation 805, a dosage history is a received via wirelesscommunication (e.g., NFC or short-range wireless communication) with thepump assembly 20. The dosage history may include data indicative of oneor more previous bolus dosages initiated by the controller device 200 ofthe pump assembly 20. In some embodiments, data included in the dosagehistory can include a date/time data point and a quantity data pointcorresponding to each of the previous bolus dosages. In operation 810,the user's current blood glucose is received. As described above, theuser's current blood glucose level can be received via wirelesscommunication from the glucose monitoring device 50 a and/or the bloodglucose test strip reader 50 b, or entered manually by the user via theuser interface 42 of the mobile device 40. In operation 810, the dosagecalculator application 44 can determine a rate of change (e.g., increaseor decrease) based on the dosage history and the blood glucose level.Non-limiting examples of suitable techniques for determining the rate ofchange in the user's blood glucose level are described in U.S.application Ser. No. 12/348,162 filed on Jan. 2, 2009, the entirety ofwhich is hereby incorporated by reference. Alternatively, the user maymanually enter the rate-of-change information for his or her bloodglucose level (rather than this information being determined by thedosage calculator application 44). For example, when using a bloodglucose test strip reader 50 b, the test strip reader may store bloodglucose measurements performed by the user, which can be used todetermine the rate of change in the user's blood glucose level. Whenprompted by the dosage calculator application 44, the user may enter themost recent rate of change data. In operation 820, the user canoptionally enter data indicative of food intake (e.g., a meal that isabout to be consumed, a meal that has recently been consumed, or thelike). For example, if the user is testing his or her blood glucoselevel before consuming a meal, the user may input such food intakeinformation when inputting the blood glucose level.

After the user's blood glucose information is obtained (e.g., viaoperations 805, 810, 815, and 820), in operation 825, the dosagecalculator application 44 can determined a suggested bolus dosage basedon the obtained data. As noted above, in some embodiments, the suggestedbolus dosage value can be calculated by the dosage calculatorapplication 44 based on at least two of the three components aspreviously described: the food offsetting component, the blood glucosecorrection component, and the insulin load correction component.Non-limiting examples of suitable techniques for determining a suggestedbolus dosage are described in U.S. application Ser. No. 12/348,162 filedon Jan. 2, 2009, which (as described above) is incorporated herein byreference.

In operation 830, the dosage calculator application 44 can determine ifthe user accepts the suggested bolus dosage. For example, illustrated inFIGS. 2-3, the user can select the “YES” or “NO” option via thetouchscreen user interface 42 of the mobile device 40 to accept ordecline the suggested bolus dosage. In operation 835, if the accepts thesuggested bolus dosage (830), the dosage calculator application 44 cancause the suggested bolus dosage to be transmitted to the infusion pumpassembly 20 (e.g., in the form of a trigger signal via NFC orshort-range wireless communication). If the user declines the suggestedbolus dosage (840), the dosage calculator application 44 can prompt theuser for a modified dosage. In operation 840, the dosage calculatorapplication 44 can determine if the user wishes to receive a modifiedbolus dosage. In operation 845, if the user wishes to receive a modifiedbolus dosage (840), the dosage calculator application 44 can obtain themodified bolus dosage. For example, the user can enter a modified bolusdosage or provide additional data that can be used to calculate amodified dosage via the user interface 42. In operation 850, the dosagecalculator application 44 can cause the modified bolus dosage to betransmitted to the pump assembly 20 (e.g., in the form of a triggersignal via NFC or short-range wireless communication). After a suggested(835) or modified (850) bolus dosage has been transmitted to the pumpassembly, or after the user has declined the suggested and modifieddosages (840), the process 800 can return to operation 802, where thedosage calculator application can wait for a subsequent trigger toinitiate a bolus dosage calculation.

Various embodiments described herein include the mobile device 40 in theform of a smartphone device. The smartphone device 40 may store orotherwise execute the previously described dosage calculator application44, and may further include other applications, computing sub-systems,and hardware. For example, a call handling unit may receive anindication of an incoming telephone call and provide a user thecapability to answer the incoming telephone call. A media player mayallow a user to listen to music or play movies that are stored in localmemory of the smartphone device 40. The smartphone device 40 may includea digital camera sensor, and corresponding image and video capture andediting software. An internet browser may enable the user to viewcontent from a web page by typing in an addresses corresponding to theweb page or selecting a link to the web page.

Additionally, the smartphone device 40 may include an antenna towirelessly communicate information with one or more base stations of amobile telephone cellular network that enables the smartphone device 40to maintain communication with a network as the smartphone device 40 isgeographically moved. The smartphone device 40 may alternatively oradditionally communicate with the network through a Wi-Fi router or awired connection (e.g., ETHERNET, USB, or FIREWIRE).

Also, the smartphone device 40 can connect with an application store toprovide a user of the smartphone device 40 the ability to browse a listof remotely stored application programs (such as the dosage calculatorapplication 44 or other mobile applications) that the user may downloadover the network and install on the mobile computing device. Theapplication store may serve as a repository of applications developed bythird-party application developers. An application program (such as thedosage calculator application 44) that is installed on the smartphonedevice 40 may be able to communicate over the network with serversystems that are designated for the application program. The smartphonedevice 40 may access cloud-based application programs, and the dosagecalculator application 44 may be implemented as such as cloud-baseapplication program. Cloud-computing provides application programs(e.g., a word processor or an email program) that are hosted remotelyfrom the smartphone device 40, and may be accessed by the smartphonedevice 40 using a web browser or a dedicated program. In the embodimentdescribed above, the smartphone device 40 stores the computer readableinstructions so as to activate the dosage calculator application 44,which can be installed and run on the smartphone device 40 or can atleast partially hosted at a server as part of a cloud-based applicationprogram. These and other services may be implemented in a server system.A server system may be a combination of hardware and software thatprovides a service or a set of services. For example, a set ofphysically separate and networked computerized devices may operatetogether as a logical server system unit to handle the operationsnecessary to offer a service to hundreds of computing devices.

A number of embodiments of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the spirit and scope of the invention.Accordingly, other embodiments are within the scope of the followingclaims.

1-20. (canceled)
 21. A method of operating a portable infusion pumpsystem, the method comprising: receiving, by a controller of theportable infusion pump system, a wireless communication from a firstcomputing device that is indicative of a task to be performed by theportable infusion pump system, wherein the wireless communication isinitiated in response to first user interaction with the first computingdevice; and in response to receiving the wireless communication,prompting user confirmation that the task indicated by the wirelesscommunication should be performed; receiving, by the controller, asignal indicating user confirmation that the task indicated by thewireless communication should be performed, wherein the signal isgenerated in response to second user interaction with a second computingdevice, the second computing device being distinct from the firstcomputing device; and causing, by the controller and in response toreceiving the signal indicating user confirmation that the taskindicated by the wireless communication should be performed, theportable infusion pump system to perform the task.
 22. The method ofclaim 21, wherein the second computing device is the controller.
 23. Themethod of claim 22, wherein: the task to be performed by the portableinfusion pump system is administration of a bolus dosage; the firstcomputing device is a mobile device; the first user interaction with thefirst computing device comprises user interaction with a user interfaceof the mobile device to cause a dosage calculator executing on themobile device to calculate a value for the bolus dosage; and causing theportable infusion pump system to perform the task comprises controlling,by the controller, a pump drive system of the portable infusion pumpsystem to cause the pump drive system to administer the bolus dosage.24. The method of claim 22, wherein: the first computing device is amobile device; the first user interaction with the first computingdevice comprises user interaction with a touch screen of the mobiledevice; and second user interaction with the second computing devicecomprises user selection of a button of the controller.
 25. The methodof claim 22, wherein: the first computing device is a mobile device; thefirst user interaction with the first computing device comprises userinteraction with a touch screen of the mobile device; and the seconduser interaction with the second computing device comprises userinteraction with a touch screen of the controller.
 26. The method ofclaim 22, wherein the signal indicating user confirmation that the taskindicated by the wireless communication should be performed isgenerated, at least in part, in based on information generated by anaccelerometer of the controller.
 27. The method of claim 26, furthercomprising: determining, by the controller, that the signal isindicative of user confirmation that the task indicated by the wirelesscommunication should be performed by comparing a movement valuerepresentative of movement detected by the accelerometer of thecontroller to a threshold value to determine that the movement valuemeets or exceeds a threshold value; wherein the step of causing theportable infusion pump system to perform the task is performed inresponse to the determination by the controller that the movement valuemeets or exceeds the threshold value.
 28. The method of claim 26,further comprising: receiving a second wireless communication from thefirst computing device; and using the information generated by theaccelerometer of the controller and information included in the secondwireless communication to determine that a user has performed a bumpaction between the controller and the first computing device; whereinthe step of causing the portable infusion pump system to perform thetask is performed in response to the determination that the user hasperformed the bump action between the controller and the first computingdevice.
 29. The method of claim 28, wherein the information included inthe second wireless communication includes information generated by thefirst computing device based at least in part on signals generated by anaccelerometer of the first computing device.
 30. The method of claim 28,wherein the information included in the second wireless communicationincludes information indicating that the first computing device iswithin a threshold distance of the controller.
 31. The method of claim22, further comprising: receiving a second wireless communication fromthe first computing device; determining, by the controller, a signalstrength of the second wireless communication; and comparing, by thecontroller, the signal strength of the second wireless communication toa threshold value to determine that the signal strength meets or exceedsthe threshold value; wherein the step of causing the portable infusionpump system to perform the task is performed in response to thedetermination that the signal strength meets or exceeds the thresholdvalue.
 32. The method of claim 31, wherein the first wirelesscommunication is received via a Bluetooth communication protocol and thesecond wireless communication is received via a near field communication(NFC) communication protocol that is distinct from the Bluetoothcommunication protocol.
 33. The method of claim 31, wherein the firstwireless communication is received via a Wi-Fi communication protocoland the second wireless communication is received via a near fieldcommunication (NFC) communication protocol that is distinct from theWi-Fi communication protocol.
 34. The method of claim 22, wherein thesecond user interaction with the second computing device comprises auser tapping the controller.
 35. The method of claim 22, wherein thesecond user interaction with the second computing device comprises abump interaction between the first computing device and the controller.36. A method of operating a portable infusion pump system, the methodcomprising: receiving, by a controller of the portable infusion pumpsystem, a wireless communication from a mobile computing device, thewireless communication indicating a task to be performed by the portableinfusion pump system; and receiving, by the controller, one or moresignals generated by an accelerometer of the portable infusion pumpsystem; determining, by the controller and using the one or more signalsgenerated by the accelerometer, user confirmation of the task indicatedby the wireless communication; and causing, by the controller and inresponse to determining user conformation of the task indicated by thewireless communication, the portable infusion pump system to perform thetask.
 37. The method of claim 36, wherein the controller and theaccelerometer are both physical components of a portable infusion pump,wherein the portable infusion pump further includes a pump drive system.38. The method of claim 37, wherein: the task to be performed by theportable infusion pump system is administration of a bolus dosage; thefirst computing device is a mobile device; the first user interactionwith the first computing device comprises user interaction with a userinterface of the mobile device to cause a dosage calculator executing onthe mobile device to calculate a value for the bolus dosage; and causingthe portable infusion pump system to perform the task comprisescontrolling, by the controller, the pump drive system to cause the pumpdrive system to administer the bolus dosage.
 39. The method of claim 38,wherein determining user confirmation of the task indicated by thewireless communication comprises comparing a movement detected by theaccelerometer to a threshold value to determine that the movement meetsor exceeds the threshold value.
 40. The method of claim 39 furthercomprising: receiving a second wireless communication from the firstcomputing device; and determining, by the controller, a signal strengthof the second wireless communication; wherein determining userconfirmation of the task indicated by the wireless communication furthercomprises comparing, by the controller, the signal strength of thesecond wireless communication to a second threshold value to determinethat the signal strength meets or exceeds the second threshold value.